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Nitroglycerin for Migraine
N/A
Recruiting
Led By Andrew Kobets, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minutes
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a new imaging tool can help show changes in blood vessels during migraine headaches.
Who is the study for?
This trial is for adults with a neurologist-confirmed diagnosis of migraine, experiencing migraines at least twice a month and not responding to standard treatments. Participants must have had stable neurological exams in the past 6 months and be willing to undergo angiography. Pregnant women, children, those with severe pulmonary or cardiac conditions, recent caffeine or alcohol intake, or on certain medications are excluded.
What is being tested?
The study aims to understand migraine pain by using nitroglycerin-induced dilation of blood vessels during an angiogram to simulate migraine symptoms. Researchers will observe changes in vessel flow during headache attacks which could inform future treatment strategies.
What are the potential side effects?
Nitroglycerin can cause headaches resembling migraines (which is part of the study), as well as dizziness, flushing, low blood pressure, and increased heart rate. It's important that participants report any discomfort they experience during the procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Migraine
Secondary study objectives
Adverse reactions
Artery dilation
Migraine log follow-up post-procedure: aggravating factor measure
+16 moreSide effects data
From 2019 Phase 4 trial • 66 Patients • NCT0220963638%
Non-serious adverse events
3%
Hospitalization
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lanthanum Carbonate
Placebo
Placebo- Phosphorus Balance Sub-study
Lanthanum Carbonate- Phosphorus Balance Sub-study
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Migraine InterventionExperimental Treatment1 Intervention
Subjects who will be administered 200 micrograms of nitroglycerin once into branches of their external carotid artery to determine the role of dilation of this artery to cause migraine-like pain
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
457 Previous Clinical Trials
588,611 Total Patients Enrolled
11 Trials studying Migraine
1,972 Patients Enrolled for Migraine
Andrew Kobets, MDPrincipal InvestigatorMontefiore Medical Center
David J Altschul, MDPrincipal InvestigatorMontefiore Medical Center
1 Previous Clinical Trials
200 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have not had any changes in your neurological exam in the past 6 months.You have had treatment or surgery on your brain for any brain issues in the past.You have a serious lung disease and need extra oxygen to help you breathe.You have not consumed coffee, tea, or alcohol for 12 hours before the angiogram.You have tried regular migraine treatments and still have severe, debilitating symptoms.You are currently taking certain medications that affect blood pressure and heart function.You have heart problems like blocked arteries or a history of heart attacks.You are taking medications similar to nitroglycerin, like phosphodiesterase inhibitors.You cannot use nitroglycerin or calcium channel blockers for medical reasons.Your angiography shows severe twisted or narrow blood vessels, blood vessel spasms that don't get better with medicine, or abnormal connections between blood vessels in your head.You have migraines that are different from other types of headaches.You have other types of headaches or pain syndromes.You are not able to accurately tell the doctor about your symptoms.You have been diagnosed with migraine by a neurologist.You have headaches at least two times every month.
Research Study Groups:
This trial has the following groups:- Group 1: Migraine Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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